Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Devil's claw extract (as dry root)
Holland & Barrett International Limited
Devil's claw extract (as dry root)
.
Capsule, hard
Product not subject to medical prescription
Authorised
2013-05-03
DEVIL’S CLAW HARD CAPSULES DEVIL’S CLAW ROOT EXTRACT More information on back panel P A T I E N T I N F O R M A T I O N L E A F L E T IMPORTANT NOTES PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS TRADITIONAL HERBAL MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU: • Always use this traditional herbal medicine exactly as described in this leaflet or as your doctor or pharmacist has told you • Keep this leaflet. You may need to read it again • Ask a healthcare professional e.g. a doctor or a pharmacist if you need more information or advice • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet • You must talk to a doctor if you feel worse or do not feel better after 4 weeks WHAT IS IN THIS LEAFLET 1 What this traditional herbal medicine is and what it is used for 2 What you need to know before you take this traditional herbal medicine 3 How to take this traditional herbal medicine 4 Possible side effects 5 How to store this traditional herbal medicine 6 Contents of the pack and other information 1 - W HAT THIS TRADITIONAL HERBAL MEDICINE IS AND WHAT IT IS USED FOR Nature’s Bounty Devil’s Claw Hard Capsules is a traditional herbal medicinal product used for the relief of minor joint pain in adults, exclusively based upon long-standing use. 2 - WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS TRADITIONAL MEDICINE DO NOT TAKE THIS TRADITIONAL HERBAL MEDICINE: • If you are allergic to Devil’s Claw or any of the other ingredients in this traditional herbal medicine (listed in Section 6) • If you have an ulcer (either a gastric and/or duodenal ulcer) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking this traditional herbal medicine if you: • Have heart problems and want to take this traditional herbal medicine • Have joint pain accompanied by swelling or redness of the joint, or a fever • If your symptoms worsen, persist for more than 4 weeks or new symptoms develop, consult yo read_full_document
Health Products Regulatory Authority 07 May 2019 CRN008LW2 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nature’s Bounty Devil’s Claw Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 427mg of extract (as dry extract) from _Harpagophytum procumbens_ D.C. and/or _H. zeyheri _L. Decne, radix (equivalent to 1493mg – 2133mg of Devil’s Claw root). Extraction solvent: Ethanol 60% v/v. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard Capsule (Capsules) Two piece clear hard capsules with grey/brown fill. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product for the relief of minor joint pain in adults, exclusively based upon long-standing use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral short-term use only ADULTS AND OLDER PEOPLE- Take 1 capsule 2 times daily immediately after food. Swallow the whole capsule with water. Take one capsule in the morning and one in the evening MAXIMUM DOSE: 2 CAPSULES PER DAY. Do not exceed the stated dose DURATION OF USE: If symptoms persist, worsen or do not improve after 4 weeks use of Nature’s Bounty Devil’s Claw Hard Capsules, a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. The safety of Nature’s Bounty Devils Claw Hard capsules in children and adolescents under 18 years of age has not been established as no data are available 4.3 CONTRAINDICATIONS • Do not use in cases of known hypersensitivity to Devil’s claw or any of the excipients listed in section 6.1 • The safety of Nature’s Bounty Devil’s Claw Hard Capsules in children and adolescents under 18 years of age has not been established as no data are available. • Patients with active gastric or duodenal ulcer 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE • Do not exceed the stated dose • If the symptoms worsen during the use of the medicinal product or if symptoms persist for more than 4 weeks, a qualified healthcare professional e.g. a read_full_document